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A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802162
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE February 15, 2019
Actual Primary Completion Date May 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • Cmax of D324 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Max Concentration of D324
  • AUCt of D324 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Area under the curve of D324
  • Cmax of D797 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Max Concentration of D797
  • AUCt of D797 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Area under the curve of D797
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • Cmax of D324 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Max Concentration of D324
  • AUCt of D324 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Area under the curve of D324
  • Cmax of D797 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Max Concentration of D797
  • AUCt of D797 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Area under the curve of D797
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • Cmin of D324 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Min Concentration of D324
  • Cmin of D797 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Min Concentration of D797
  • Tmax of D324 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Time of Max concentration of D324
  • Tmax of D797 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Time of Max concentration of D797
  • t½ of D324 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Half-life time of D324
  • t½ of D797 [ Time Frame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours ]
    Half-life time of D797
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • Cmin of D324 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Min Concentration of D324
  • Cmin of D797 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Min Concentration of D797
  • Tmax of D324 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Time of Max concentration of D324
  • Tmax of D797 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Time of Max concentration of D797
  • t½ of D324 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Half-life time of D324
  • t½ of D797 [ Time Frame: 0hr (predoes), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hr ]
    Half-life time of D797
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355
Official Title  ICMJE An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects
Brief Summary The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.
Detailed Description An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease (AD)
Intervention  ICMJE
  • Drug: CKD-355A (D797/Memantine HCl 20mg)
    once a day
  • Drug: CKD-355B (D797/Memantine HCl 20mg)
    once a day
  • Drug: D797
    once a day
  • Drug: D324 (Memantine HCl 10mg)
    twice a day
Study Arms  ICMJE
  • Experimental: CKD-355A
    Intervention: Drug: CKD-355A (D797/Memantine HCl 20mg)
  • Experimental: CKD-355B
    Intervention: Drug: CKD-355B (D797/Memantine HCl 20mg)
  • Active Comparator: D797, D324
    Interventions:
    • Drug: D797
    • Drug: D324 (Memantine HCl 10mg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2019
Actual Primary Completion Date May 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adult older than 19 years and less than 55 years at the time of screening
  2. BMI 18.5~29.9 kg/m2 and body weight more than 50kg
  3. Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
  4. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

  1. Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
  2. Subjects who have acute disease within 28 days prior to the first administration
  3. Subjects who have history that may affect the ADME
  4. Subjects who have clinically significant chronic disease
  5. Women who are nursing, pregnant or positive on pregnancy test
  6. Subjects who have clinically significant allergic diseases
  7. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  8. Subjects who are known to be hypersensitive to the drug or its components
  9. Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
  10. Subjects with creatinine clearance <60 ml / min
  11. Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
  12. Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
  13. Subjects who can not eat standard meals provided by the institution.
  14. Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
  15. Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
  16. Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice>1 L / day)
  17. Subjects who participate in the other clinical trial within 90 days prior to the first administration
  18. Subjects who have a history of regular alcohol(alcohol>210g/week) or caffeine(caffeine>5 cups/day)
  19. Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
  20. Subjects who is determined unsuitable to participate in this clinical trial by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03802162
Other Study ID Numbers  ICMJE 179BE18029
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chong Kun Dang Pharmaceutical
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP